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Thursday, 26 January 2017

The GingerKat has been stalking this year's patent decisionsand has already come up trumps

It has been a quick start to the year with a number of juicy little decisions coming from the Patents Court and Court of Appeal. With the AmeriKat whisker deep in her own trial preparation, she has had to rely on one of her favorite courtroom teammates and IP legal eagle, Steven Baldwin (Allen & Overy), to summarize 2017's recent patent decisions. Take it away, Steve:

Teva, Accord, Lupin and Generics (t/a Mylan) commenced invalidity proceedings against one of Gilead’s SPCs. The SPC is for a composition containing tenofovir disoproxil with emtricitabine. Gilead’s combination product is TRUVADA® - an anti-retroviral used in treating HIV. As well as the TRUVADA® combination product, Gilead markets VIREAD®, a monotherapy (tenofovir), but has not obtained an SPC for it. As regards the combination product, Gilead’s EP (UK) ‘894 patent (the basic patent) contains no Examples of one of the two compounds in combination with any other therapeutic ingredient, and emtricitabine is not mentioned in it. However, claim 27 is to “a pharmaceutical composition comprising a compound according to any one of claims 1-25 together with a pharmaceutically acceptable carrier and optionally other therapeutic ingredients” (emphasis added). Gilead argued the product described in the SPC is protected by claim 27 of the EP (UK) ‘894 patent, but Teva disputed this and said that the SPC does not comply with Art 3(a) of the SPC Regulation. In Teva’s view, the case law is clear enough and no reference to the CJEU was needed and, in any event, emtricitabine is not “specified” in claim 27. Gilead in response argued that its SPC complies with the SPC Regulation as it is enough that its product falls within the scope of one of the basic patent’s claims using the “extent of protection” rules.

The Decision

Arnold J reviewed the CJEU’s SPC decisions post-Medeva in some detail. He decided that the infringement test for Art 3(a) had clearly been rejected but also came to the conclusion that “it is not sufficient for the product in question to fall within the scope of protection of the basic patent applying the Extent of Protection Rules. Something more is required” (para 43). He then spent a significant amount of the judgment considering what this “more” is, reasoning that there is little to no guidance in the CJEU cases in this regard. His conclusion was therefore that “the test to be applied in order to determine whether a product is “protected” by a basic patent within the meaning of Article 3(a) remains unclear” (para 91), which necessitated a referral to the CJEU. In referring the question on Art 3(a) as to what was required for a product to be protected by a basic patent, he stated that he was “encouraged by what the [CJEU] said in Actavis v Sanofi and Actavis v Boehringer to believe that there is a realistic prospect of the Court providing further and better guidance to that which it has hitherto provided” (para 91). Not content to leave matters to the CJEU, Arnold J expressed his own view of what “more” is required for a product to be protected within the meaning of Art 3(a):

“What more is required? In my view, the answer is that the product must infringe because it contains an active ingredient, or a combination of active ingredients, which embodies the inventive advance, (or technical contribution) of the basic patent. Where the product is a combination of active ingredients, the combination, as distinct from one of them, must embody the inventive advance of the basic patent”.

Arnold J then went on to suggest that in the present case, a product whose active ingredients are tenofovir disoproxil (TD) and another therapeutic agent (such as emtricitabine) “is not protected by the Patent within the meaning of Article 3(a) because the combination, as distinct from TD, does not embody the inventive advance of the Patent. This is not a question of the wording of the claims of the basic patent, which….can be manipulated by the patent attorney who drafts it, but of its substance” (see paras 97 and 98 in full).

This was an appeal of the UKIPO’s decision to refuse Abraxis an SPC for paclitaxel formulated as albumin-bound nanoparticles (nab-paclitaxel, marketed as ABRAXANE®) on the basis of Art 3(d) of the SPC Regulation, i.e., that:

"the authorisation referred to in point (b) is the first authorisation to place the product on the market as a medicinal product."

In relation to SPC Regulation Art 1(b), Abraxis argued that nab-paclitaxel is a single active ingredient (not a combination of an active ingredient with an excipient or adjuvant) and is a different active ingredient to paclitaxel because the binding to albumin has important therapeutic consequences. Abraxis therefore argued that nab-paclitaxel is a different “product” to paclitaxel under Art 1(b) and therefore the SPC application complies with Art 3(d) because the ABRAXANE® MA is the first authorisation to place nab-paclitaxel on the market. The UK IPO hearing officer had found that nab-paclitaxel was not a single active, but a combination of active and non-active ingredients. Arnold J held that it was clear for the purposes of SPC Regulation Art 1(b) that paclitaxel is the active and albumin is a carrier. There is no need to refer a question on art 1(b) to the CJEU because the law is clear from the CJEU decisions in MIT, GSK and Forsgren that Art 1(b) is to be interpreted narrowly (para 56). However, Arnold J did think it necessary to refer a question to the CJEU on the scope of Art 3(d) in this context.

The Decision

Arnold J held that the uncertainty in the law surrounding Arts 1(b) and 3(d) SPC Regulation arose from the decision in Neurim. He notes that the Neurim decision seems to be inconsistent with the CJEU’s decisions in MIT, GSK, Pharmaciaand Yissum. Whilst he could see how the decisions in MIT and GSK could still be consistent with Neurim (in that Art 3(d) could be interpreted more widely to encompass second medical uses, even if Art 1(b) was interpreted narrowly), he could not see how Neurim is consistent with Pharmacia or Yissum. This inconsistency was an issue since Abraxis were arguing, inter alia, that in light of the Neurim decision they should be able to obtain an SPC for a new formulation of a known active ingredient. Given the inconsistency between the CJEU case law, Arnold J has proposed asking the CJEU the following question:

“Is Art 3(d) of the SPC Regulation to be interpreted as permitting the grant of an SPC where the marketing authorisation referred to in Art 3(b) is the first authorisation within the scope of the basic patent to place the product on the market as a medicinal product and where the product is a new formulation of an old active ingredient?”

As in Teva v Gilead, Arnold J provided his own view on how the CJEU should answer the proposed question. He thinks the correct answer is “no”. Essentially, he considers that if Art 1(b) is narrowly interpreted, it would be inconsistent to construe Art 3(d) more broadly to allow SPCs for new formulations of known active ingredients.

He also said that construing Art 3(d) to allow SPCs for new formulations of known active ingredients would also cause uncertainty about exactly when an SPC for a new formulation could be obtained. Indeed, his view is that “...the SPC Regulation aims to balance the interests of patentees with those of other stakeholders. To achieve those objectives, it is necessary to have bright-line rules even if they sometimes deprive meritorious inventions of extended protection”. Further, his view is that whilst the Commission intended the SPC Regulation to cover second medical uses, such intention did not extend to new formulations of known actives. In support of this view he cited paras 11 and 12 of the European Commission’s Explanatory Memorandum proposing the first SPC Regulation in 1992, which appears to support his position. [Hmmm...the Merpe may have some more to say about this later with some references from the Explanatory Memos of her own to cite...]

The Appellant (Wobben) was the proprietor of EP (UK) 0 847 496, with a priority date of 1 September 1995, relates to a method of operating pitch-controlled wind turbines in high wind speeds. At that time, turbines were commonly shut down at wind speeds in excess of 25m/s. While the majority of turbines in commercial use at the priority date were fixed-speed turbines, the industry had become focused on "variable speed, variable pitch" (VSVP) turbines, in which both the torque and the pitch of the rotor could be varied depending on the wind speed. In the first instance proceedings before Mr Justice Birss, Wobben claimed that the defendants (collectively Siemens) had infringed the patent by installing wind turbines at a number of off-shore sites. Siemens disputed infringement and also contended that the patent was invalid for lack of novelty, obviousness and insufficiency. Birss J found the patent invalid for obviousness in light of an article published in 1982 by Dr Ervin Bossanyi (Bossanyi). He also held that, if the patent were valid, it would not have been infringed. Wobben attacked this finding on the basis that the judge wrongly directed himself as to the legal test for obviousness and made a series of fundamental errors in assessing the evidence of the expert witnesses. It also argued that the judge erred in assessing infringement and made findings which had no basis in the evidence.

The Decision

The Court of Appeal (Kitchin LJ giving the lead judgment) dismissed Wobben’s appeal. As regards inventive step the judge had appreciated that the teaching of Bossanyi related to fixed-speed rather than VSVP turbines, and he had been entitled to hold that the skilled person reading Bossanyi in 1995 would have considered implementing it on a VSVP turbine. Wobben argued that the skilled person thinking of applying Bossanyi's teaching to a VSVP turbine would have simply followed the common general knowledge approach of "feathering" the rotor to reduce the power extracted from the wind while maintaining the set rotor speed. However, Kitchin J rejected this argument, holding instead that the judge was “entitled to step back and consider, as he did, the wider picture”.

At the priority date turbines were shut down at a wind speed of 25 m/s to avoid the loads and fatigue associated with running the turbine in higher wind speeds. Bossanyi proposed that a turbine should be kept running above the wind speed at which a turbine would normally be shut down. Concern about the static and dynamic loads and the fatigue experienced by the turbine would therefore be of great importance to the skilled person thinking of implementing Bossanyi’s teaching and so he would naturally consider how these problems could be mitigated. There could be no criticism of Birss J’s conclusion in this regard since it had a proper basis in the expert evidence and the common general knowledge at the priority date. Further, while the teaching of Bossanyi concerned fixed-speed turbines, the most relevant aspect of its teaching was concerned not with the nature of the turbine but with its operation at wind speeds above the normal shut-down speed. By the time of the priority date, the industry was focused on VSVP turbines, and the two critical questions were whether the skilled person would see anything in Bossanyi worth implementing and, if so, how that would be done. The judge could not be criticised for the way he had answered those questions (see, in particular paras 61-64, 70, 74-77, 82-83 of judgment).

Kitchin LJ also held that Birss J was correct in his approach to infringement, finding that he came to the correct conclusion."

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